Docetaxel, Trabectedin, and G-CSF or Pegfilgrastim in Treating Patients With Recurrent or Persistent Ovarian Epithelial Cancer, Primary Peritoneal Cavity Cancer, or Fallopian Tube Cancer

NCT00569673 | Completed Phase 2 Results

• 2 other identifiers: GOG-0186FCDR0000577866
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 37

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and trabectedin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Colony-stimulating factors, such as G-CSF and pegfilgrastim, may help the immune system recover from the side effects of chemotherapy. Giving combination chemotherapy together with G-CSF or pegfilgrastim may kill more tumor cells. PURPOSE: This phase II trial is studying the side effects and how well giving docetaxel and trabectedin together with G-CSF or pegfilgrastim works in treating patients with recurrent or persistent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.

Conditions

Fallopian Tube Cancer; Ovarian Cancer; Primary Peritoneal Cavity Cancer

Keywords

recurrent ovarian epithelial cancer; fallopian tube cancer; primary peritoneal cavity cancer

Outcome Measures

Primary Outcomes (2)

• Objective Tumor Response

  Response is measured according to Response Evaluation Criteria in Solid Tumors Criteria (RECIST v 1.0): Complete Response (CR) is disappearance of all target and non-target lesions and no evidence of new lesions documented by two disease assessments at least 4 weeks apart. Partial Response (PR) is at least a 30% decrease in the sum of longest dimensions (LD) of all target measurable lesions taking as reference the baseline sum of LD. Disease Progression is at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD or the appearance of new lesions within 8 weeks of study entry. Stable Disease is any condition not meeting the above criteria. Indeterminate is defined as having no repeat tumor assessments following initiation of study therapy6

  every other cycle for the first 6 months; then every 3 months thereafter (up to 5 years)

• Number of Participants With Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0

  Prior to each cycle and 30 days after the last cycle (average of 5 months)

Secondary Outcomes (1)

• Duration of Progression-free Survival and Overall Survival

  up to 5 years

Interventions

filgrastim BIOLOGICAL

pegfilgrastim BIOLOGICAL

docetaxel DRUG

trabectedin DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity carcinoma * Recurrent or persistent disease * Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension (longest dimension to be recorded) ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan * Must have at least 1 "target lesion" to be used to assess response on this protocol as defined by RECIST criteria * Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy * Must have had 1 prior platinum-based chemotherapeutic regimen for management of primary disease containing carboplatin, cisplatin, or another organoplatinum compound and the initial treatment may have included high-dose therapy, consolidation, or extended therapy administered after surgical or non-surgical assessment * Patients are allowed, but not required to receive, 2 additional cytotoxic regimens for management of recurrent or persistent disease with no more than 1 non-platinum, non-taxane regimen * Patients who have received only 1 prior cytotoxic regimen (platinum-based regimen for management of primary disease), must meet 1 of the following criteria: * Platinum-free interval of \< 12 months * Progressed during platinum-based therapy * Persistent disease after a platinum-based therapy * Not eligible for a higher priority GOG protocol (i.e., any active GOG Phase III protocol for the same patient population) PATIENT CHARACTERISTICS: * GOG performance status (PS) 0-2 or after receiving 1 prior treatment regimen (GOG PS 0-1 after receiving 2 or more prior regimens) * Platelet count ≥ 100,000/mm³ * ANC count ≥ 1,500/mm³ * Hemoglobin \> 9 g/dL * Creatinine ≤ 1.5 times upper limit normal (ULN) * AST and ALT ≤ 2.5 times ULN * CPK normal * Bilirubin or direct bilirubin normal * Alkaline phosphatase normal * Neuropathy (sensory and motor) ≤ grade 1 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No active infection requiring antibiotics (except for uncomplicated UTI) * No other invasive malignancy within the past 5 years, except nonmelanoma skin cancer * No known active liver disease or hepatitis * Willing and able to have a central venous catheter PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from effects of recent surgery, radiotherapy, or chemotherapy * At least 1 week since prior hormonal therapy directed at the malignant tumor * Continuation of hormone replacement therapy allowed * At least 3 weeks since other prior therapy, including biological and immunological therapy directed at the tumor * Chimeric or human or humanized monoclonal antibodies must be discontinued for at least 6 weeks prior to study entry * No investigational therapy within the past 30 days * No prior therapy with docetaxel and/or trabectedin * No radiation to more than 25% of marrow-bearing areas * No prior cancer treatment that contraindicates protocol therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Gynecologic Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (37)

Providence Saint Joseph Medical Center - Burbank

Burbank, California, 91505, United States

Location

Jonsson Comprehensive Cancer Center at UCLA

Los Angeles, California, 90095-1781, United States

Location

George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus

New Britain, Connecticut, 06050, United States

Location

Tunnell Cancer Center at Beebe Medical Center

Lewes, Delaware, 19958, United States

Location

CCOP - Christiana Care Health Services

Newark, Delaware, 19713, United States

Location

Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center

Savannah, Georgia, 31403-3089, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Hinsdale Hematology Oncology Associates

Hinsdale, Illinois, 60521, United States

Location

St. Vincent Indianapolis Hospital

Indianapolis, Indiana, 46260, United States

Location

Union Hospital Cancer Program at Union Hospital

Elkton, Maryland, 21921, United States

Location

UMASS Memorial Cancer Center - University Campus

Worcester, Massachusetts, 01655, United States

Location

St. John's Regional Health Center

Springfield, Missouri, 65804, United States

Location

Hulston Cancer Center at Cox Medical Center South

Springfield, Missouri, 65807, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Cancer Institute of New Jersey at Cooper - Voorhees

Voorhees Township, New Jersey, 08043, United States

Location

University of New Mexico Cancer Center

Albuquerque, New Mexico, 87131-5636, United States

Location

Alamance Cancer Center at Alamance Regional Medical Center

Burlington, North Carolina, 27216, United States

Location

Blumenthal Cancer Center at Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MetroHealth Cancer Care Center at MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Cleveland Clinic Cancer Center at Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center

Columbus, Ohio, 43210-1240, United States

Location

Riverside Methodist Hospital Cancer Care

Columbus, Ohio, 43214-3998, United States

Location

Mount Carmel Health - West Hospital

Columbus, Ohio, 43222, United States

Location

David L. Rike Cancer Center at Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

Hillcrest Cancer Center at Hillcrest Hospital

Mayfield Heights, Ohio, 44124, United States

Location

Lake/University Ireland Cancer Center

Mentor, Ohio, 44060, United States

Location

Oklahoma University Cancer Institute

Oklahoma City, Oklahoma, 73104, United States

Location

Rosenfeld Cancer Center at Abington Memorial Hospital

Abington, Pennsylvania, 19001, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

UPMC Cancer Center at Magee-Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

Location

Huntsman Cancer Institute at University of Utah

Salt Lake City, Utah, 84112, United States

Location

Carilion Gynecologic Oncology Associates

Roanoke, Virginia, 24014, United States

Location

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792-6164, United States

Location

Related Publications (2)

• Monk BJ, Sill MW, Hanjani P, Edwards R, Rotmensch J, De Geest K, Bonebrake AJ, Walker JL. Docetaxel plus trabectedin appears active in recurrent or persistent ovarian and primary peritoneal cancer after up to three prior regimens: a phase II study of the Gynecologic Oncology Group. Gynecol Oncol. 2011 Mar;120(3):459-63. doi: 10.1016/j.ygyno.2010.11.012. Epub 2010 Dec 7.

  PMID: 21144560 RESULT

• Monk, M BJ, Sill M, Walker JL, et al.: Activity of docetaxel plus trabectedin in recurrent or persistent ovarian and primary peritoneal cancer: A phase II study of the Gynecologic Oncology Group (GOG). [Abstract] J Clin Oncol 28 (Suppl 15): A-5046, 2010.

  RESULT

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Filgrastim; pegfilgrastim; Docetaxel; Trabectedin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Jessalyn Reboy
• Organization: NRG Oncology, Statistics and Data Management Center, Buffalo Office

ReboyJ@nrgoncology.org

716-845-7738

Study Officials

• Bradley J. Monk, MD

  Chao Family Comprehensive Cancer Center

  STUDY CHAIR

• Kristine M. Zanotti, MD

  MacDonald Physicians, Incorporated at University MacDonald Womens Hospital

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2007
• First Posted: December 7, 2007
• Study Start: March 1, 2008
• Primary Completion: January 1, 2012
• Last Updated: July 18, 2018
• Results First Posted: June 26, 2014

Record last verified: 2014-05

Locations

US (37)